U.S. patent application number 13/250144 was filed with the patent office on 2013-04-04 for catheter with external flow channel.
This patent application is currently assigned to TYCO HEALTHCARE GROUP LP. The applicant listed for this patent is Richard M. Braga, Thomas M. Johnston, Arnaz S. Malhi. Invention is credited to Richard M. Braga, Thomas M. Johnston, Arnaz S. Malhi.
Application Number | 20130085478 13/250144 |
Document ID | / |
Family ID | 46796470 |
Filed Date | 2013-04-04 |
United States Patent
Application |
20130085478 |
Kind Code |
A1 |
Malhi; Arnaz S. ; et
al. |
April 4, 2013 |
CATHETER WITH EXTERNAL FLOW CHANNEL
Abstract
A catheter is provided which includes a body having a proximal
end, a distal end and a sidewall defining at least one lumen. The
catheter body has at least one side opening formed through the
sidewall at a location spaced proximally from the distal end. The
at least one side opening communicates with the at least one lumen.
A recess extends along the sidewall and communicates with the at
least one side opening such that the recess defines a fluid pathway
into the side opening.
Inventors: |
Malhi; Arnaz S.; (Watertown,
MA) ; Braga; Richard M.; (North Easton, MA) ;
Johnston; Thomas M.; (Westborough, MA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Malhi; Arnaz S.
Braga; Richard M.
Johnston; Thomas M. |
Watertown
North Easton
Westborough |
MA
MA
MA |
US
US
US |
|
|
Assignee: |
TYCO HEALTHCARE GROUP LP
Mansfield
MA
|
Family ID: |
46796470 |
Appl. No.: |
13/250144 |
Filed: |
September 30, 2011 |
Current U.S.
Class: |
604/523 |
Current CPC
Class: |
A61M 1/3661 20140204;
A61M 1/3653 20130101; A61M 1/3659 20140204; A61M 25/0068 20130101;
A61M 2025/0031 20130101; A61M 25/0028 20130101; A61M 25/0029
20130101; A61M 25/007 20130101 |
Class at
Publication: |
604/523 |
International
Class: |
A61M 25/00 20060101
A61M025/00 |
Claims
1. A catheter comprising: a body having a proximal end and a distal
end, the body including a sidewall defining at least one lumen and
at least one side opening formed through the sidewall at a location
spaced proximally from the distal end, the at least one side
opening communicating with the at least one lumen, and further
including a recess extending along the sidewall and communicating
with the at least one side opening, the recess defining a fluid
pathway into the side opening.
2. The catheter according to claim 1, wherein the body defines at
least one distal opening which communicates with the at least one
lumen, the at least one distal opening being positioned distally of
the at least one side opening.
3. The catheter according to claim 2, wherein the at least one
lumen includes a first lumen and a second lumen.
4. The catheter according to claim 3, wherein the at least one side
opening includes a first side opening and a second side
opening.
5. The catheter according to claim 4, wherein the recess includes
first and second recesses, the first and second recesses
communicating with the first and second side openings,
respectively.
6. The catheter according to claim 1, wherein the at least one
recess is substantially linear.
7. The catheter according to claim 1, wherein the at least one
recess is non-linear.
8. The catheter according to claim 2, wherein the at least one
recess extends proximally from the at least one side opening.
9. The catheter according to claim 2, wherein the at least one
recess extends distally from the at least one side opening.
10. The catheter according to claim 8, wherein the at least one
recess includes a plurality of recesses communicating with the at
least one side opening.
11. The catheter according to claim 9, wherein the least least one
recess includes a plurality of recesses communicating with the at
least one side opening.
12. The catheter according to claim 1, wherein the at least one
recess has a length of about 0.5 cm to about 1.0 cm.
13. The catheter according to claim 1, wherein a portion of the
sidewall defining a base of the recess has a thickness which
decreases in a direction towards the side opening.
14. The catheter according to claim 1, wherein a portion of the
sidewall defining a base of the recess slopes downwardly towards
the side opening.
15. The catheter according to claim 1, wherein a portion of the
sidewall defining a base of the recess includes an undulating
surface.
Description
TECHNICAL FIELD
[0001] The present disclosure relates to catheters for use in
medical procedures, and in particular, to catheters for withdrawing
fluids from the body during medical procedures.
BACKGROUND
[0002] Catheters are flexible medical instruments for use in the
introduction and withdrawal of fluids to and from body cavities,
ducts and vessels. Catheters are used for many different
applications within the human body including the administration of
liquid therapeutic agents and the removal of bodily fluids for
testing, monitoring, or disposal. Catheters have a particular
application in hemodialysis procedures, in which blood is withdrawn
from a blood vessel, directed to a hemodialysis unit for dialysis
or purification, and subsequently returned to the blood vessel.
[0003] Typically, dialysis catheters define at least two lumens
including a venous lumen and an arterial lumen. The arterial lumen
withdraws blood from the patient and delivers the blood to a
dialysis machine. The venous lumen receives blood from the dialysis
machine and returns the blood to the patient. The venous and
arterial lumens may include distal openings adjacent the tip of the
catheter. In addition, the venous and arterial lumens may also
include side openings which provide redundant or alternate flow
paths to and from the arterial and venous lumens.
[0004] When a catheter is placed in a body cavity and fluid is
withdrawn through a lumen of the catheter, e.g., the arterial
lumen, the catheter opening or openings communicating the catheter
lumen with the body cavity may become occluded. More specifically,
because the catheter lumen for withdrawing fluid from a vessel
draws a vacuum adjacent the openings, body tissue may be drawn into
the distal and/or side openings of the arterial lumen and occlude
the openings. Although the redundant flow paths created by
providing both distal and side openings reduce the likelihood of
total occlusion of the catheter withdrawal lumen, further
improvements to known catheters to further reduce the likelihood of
vessel occlusion are desireable.
[0005] Therefore, it would be desireable to overcome the
disadvantages associated with known catheters by providing a
catheter which is less susceptible to occlusion and capable of
providing unobstructed fluid flow into the catheter.
SUMMARY
[0006] A catheter in accordance with the present disclosure
includes a body having a proximal end and a distal end. The
catheter body includes a sidewall defining at least one lumen and
at least one side opening formed through the sidewall at a location
spaced proximally from the distal end. The at least one side
opening communicates with the at least one lumen. A recess extends
along the sidewall and communicates with the at least one side
opening to define a fluid pathway into the side opening.
[0007] In one embodiment, the body defines at least one distal
opening which communicates with the at least one lumen and is
positioned distally of the at least one side opening.
[0008] In one embodiment, the at least one lumen includes a first
lumen and a second lumen and the at least one side opening includes
first and second side openings. First and second recesses may be
provided to communicate with the first and second side openings,
respectively.
[0009] In one embodiment, the at least one recess is substantially
linear. Alternately, the at least one recess may be non-linear.
[0010] The at least one recess may extend proximally from the at
least one side opening. Alternately, the at least one recess may
extend distally from the at least one side opening.
[0011] In one embodiment, the at least one recess includes a
plurality of recesses communicating with each of the at least one
side openings. The plurality of recess may be linear or non-linear
and may extend proximally or distally from the side opening.
[0012] In one embodiment, a portion of the sidewall defining a base
of the recess has a thickness which decreases in a direction
towards the side opening. Similarly, a portion of the sidewall
defining a base of the recess may slope downwardly towards the side
opening.
[0013] In another embodiment, a portion of the sidewall defining a
base of the recess includes an undulating surface.
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] Various embodiments of the present disclosure will be
described herein with reference to the accompanying drawings,
wherein:
[0015] FIG. 1 is a perspective view of the distal end of one
embodiment of the presently disclosed catheter;
[0016] FIG. 2 is a side, cross-sectional view of a portion of the
distal end of the catheter shown in FIG. 1;
[0017] FIG. 2A is a side, cross-sectional view of a distal end of
an alternative embodiment of the catheter shown in FIG. 1;
[0018] FIG. 3 is a cross-sectional view taken along section lines
3-3 of FIG. 1;
[0019] FIG. 4 is a perspective view of the distal end of another
embodiment of the presently disclosed catheter;
[0020] FIG. 5 is a cross-sectional view taken along section lines
5-5 of FIG. 4;
[0021] FIG. 6 is a side perspective view of the distal end of yet
another embodiment of the presently disclosed catheter;
[0022] FIG. 7 is a perspective view of the distal end of another
embodiment of the presently disclosed catheter;
[0023] FIG. 8 is a cross-sectional view taken along section lines
8-8 of FIG. 7;
[0024] FIG. 9 is a side cross-sectional view of a distal portion of
another embodiment of the presently disclosed catheter;
[0025] FIG. 9A is a transverse cross-sectional view of the catheter
of FIG. 9;
[0026] FIG. 10 is a side cross-sectional view of the catheter shown
in FIG. 9 as fluid enters the catheter through the side
opening;
[0027] FIG. 10A is a transverse cross-sectional view of the
catheter of FIG. 10;
[0028] FIG. 11 is a side cross-sectional view of the catheter shown
in FIG. 9 as fluid is discharged from the side opening of the
catheter;
[0029] FIG. 11A is a transverse cross-sectional view of the
catheter of FIG. 11; and
[0030] FIG. 12 is a side cross-sectional view of a distal portion
of another embodiment of the presently disclosed catheter.
DETAILED DESCRIPTION OF EMBODIMENTS
[0031] Various exemplary embodiments of the presently disclosed
catheter are discussed herein in terms of a hemodialysis catheter.
However, it is envisioned that the principles of the present
disclosure are equally applicable to a range of catheter
applications such as, for example, hemodialysis, cardiac,
abdominal, urinary, and intestinal, including both chronic and
acute applications. Moreover, the catheter can be used for the
delivery and/or withdrawal of fluids such as, for example,
medication, saline, bodily fluids, blood and urine.
[0032] In the following discussion, the terms "proximal" and
"trailing" may be employed interchangeably, and should be
understood as referring to the portion of a structure that is
closer to a clinician during proper use. The terms "distal" and
"leading" may also be employed interchangeably, and should be
understood as referring to the portion of a structure that is
further from the clinician during proper use. As used herein, the
term "patient" should be understood as referring to a human patient
or other animal, and the term "clinician" should be understood as
referring to a doctor, nurse or other care provider and may include
support personnel.
[0033] FIGS. 1-3 illustrate one embodiment of the presently
disclosed catheter shown generally as 10. Catheter 10 includes a
catheter body 12 defining a first lumen 14 and a second lumen 16.
As illustrated, first and second lumens 14 and 16 are substantially
D-shaped. Alternately, it is envisioned that lumens 14 and 16 may
have a variety of configurations including circular. A septum 18
extends from the proximal end of the body 10 to the distal end of
body 10. In one embodiment, the septum 18 extends distally of a
distal end of the sidewalls 20 defining the outer perimeter of body
12.
[0034] Body 12 defines a pair of distal openings 22 and a pair of
diametrically opposed side openings 24 which are spaced proximally
of the distal openings 22. In one embodiment, each distal opening
22 is defined between septum 18 and distal spirally configured
sidewall extensions 26 of sidewalls 20. A catheter including
similarly configured distal sidewall extensions 26 is disclosed in
U.S. Pat. No. 7,776,005 which is incorporated herein by reference
in its entirety. Alternately, it is envisioned that the distal end
of the catheter 10 may assume a variety of configurations known in
the art.
[0035] Side openings 24 are formed through sidewalls 20 of catheter
body 12 at locations spaced proximally of distal openings 22. Each
opening 24 communicates with a respective one of the first and
second lumens 14 and 16. As illustrated, openings 24 are positioned
in diametrically opposed locations on body 10. Alternatively,
openings 24 may not be diametrically opposed. Although openings 24
are illustrated as having an oval configuration, other
configurations including polygonal, rectangular, square,
trapezoidal, circular, and other regular and irregular shaped
openings are envisioned.
[0036] As shown in FIGS. 1-3, a recess 32 is defined in sidewall 20
proximally to each side opening 24. The recess 32 may define a
spherical concavity, a rectangular channel or have any desired
configuration which defines a channel positioned below the outer
surface of sidewall 20. Each recess 32 communicates with a side
opening 24 to define an additional flow path into a respective one
of first and second lumens 14 and 16. As will be discussed in
further detail below, by providing an additional flow path which
communicates with the side openings 24, if a side opening 24
becomes occluded, the additional flow path provides a means for
maintaining the patency of the side opening 24.
[0037] In one embodiment, the length of the recess 32 is between
0.25 cm to about 3 cm. In one embodiment, the length of recess 32
is about 0.5 cm to about 1 cm. In another embodiment, the length of
the recess 32 is about 2 cm.
[0038] When catheter 10 is used in a medical procedure, for
example, a hemodialysis procedure, the catheter 10 is placed in a
vein, typically the superior vena cava for a central venous
catheter, through the internal jugular vein in the neck and
advanced downwards toward the chest. The proximal end of catheter
10 is connected to a dialyzer in a known manner such that one of
the first and second lumens 14 and 16 defines the arterial lumen of
the catheter 10 and one of the first and second lumens 14 and 16
defines the venous lumen of the catheter 10. As discussed above,
the arterial lumen is used to withdraw blood from a patient's vein
and deliver the blood to a dialyzer and the venous lumen returns
blood from the dialyzer to the patient's vein. Because a negative
pressure is effected within the arterial lumen, tissue may be drawn
into the distal opening 14, 16 and/or the side opening 24 of
catheter 10 to occlude one or both the openings. In the event that
tissue is drawn into the side opening 24 of the arterial lumen, the
recess 32 provides an alternate flow path into the side opening 24
to maintain patency of the opening and facilitate continued flow
through the side opening 24. Additionally, if the side opening 24
is resting on the vein wall and is thus occluded, the recess will
provide a means to keep the side opening 24 patent.
[0039] FIG. 2A illustrates an alternate embodiment of the catheter
10 shown generally as 10'. Catheter 10' includes a sidewall 20'
which defines a side opening 24'. A recess 32' is formed in
sidewall 20'as discussed above with respect to recess 32 of
catheter 10. In addition, the portion 33' of the sidewall 20' in
which the recess 32' is formed is deformed downwardly such that an
outer surface of portion 33' defines a downwardly sloped surface
which is directed into side opening 24' and arterial lumen 14'. In
one embodiment, catheter 10' can be formed by using a heated die to
press the wall portion 33' defining a bottom of recess 32' of
catheter 10 downwardly to the position shown in FIG. 2A.
Alternatively, portion 33' may be formed using any know molding or
machining process.
[0040] FIGS. 4 and 5 illustrate an alternate embodiment of the
presently disclosed catheter shown generally as 100. Catheter 100
is substantially similar to catheter 10 in all respects except that
recess 132 is positioned distally of side opening 124 between the
distal end of catheter 100 and side opening 124.
[0041] FIG. 6 illustrates another alternate embodiment of the
presently disclosed catheter shown generally as 200. Catheter 200
is substantially similar to catheter 10 in that catheter 200
includes a recess 232 which is positioned proximally of side
opening 224. However, in contrast to catheter 10, the recess 232 is
non-linear or curved. Although not shown, the curved recess 232 may
also be positioned distally of side opening 224. Curving the recess
232 may further enhance the benefits of preventing total occlusion
by locating a portion of the recess 232 further from the vessel
tissue. This may be especially true in case where the side opening
224 is resting on the vein wall.
[0042] In yet another alternative embodiment shown in FIGS. 7 and
8, catheter 300 includes a plurality of spaced recesses 332 which
are positioned proximally of and communicate with the side opening
324. Although two recesses 332 are illustrated, it is envisioned
that a multiplicity of recesses 332 may be provided either
distally, proximally, or both distally and proximally of each side
opening 324. In addition, it is envisioned that one or more of the
multiplicity of recesses 332 may be curved, linear or any
combination of curved and linear. FIG. 8A shows an alternate design
embodiment.
[0043] In another alternative embodiment shown in FIGS. 9-11A, the
catheter 400 which is illustrated as a single lumen catheter,
includes a side opening 424 and a recess 432 positioned proximally
of the side opening 424. Catheter 400 differs from catheter 10
above in that the portion of sidewall 420 defining the bottom wall
420a of recess 432 is tapered downwardly in a distal direction
towards side opening 424, i.e., the thickness of the sidewall 420
at the base of the recess 432 decreases in the distal direction.
Such a configuration enables the bottom wall 420a to flex slightly
inwardly (FIG. 10) into lumen 414 when lumen 414 functions as the
arterial lumen or flex slightly outwardly (FIG. 11) when lumen 414
functions as the venous lumen. The flexibility of bottom wall 420a
of recess 432 allows fluid to more smoothly flow into and out of
catheter 400 during use. The thicker proximal portion of bottom
wall 420 adds some rigidity to the bottom wall 420a to limit the
degree to which the bottom wall 420a is able to flex.
[0044] As shown in yet another embodiment of the presently
disclosed catheter shown generally as 500, the entire length of
bottom wall 520a defining recess 532 can be thinned to provide a
greater flexibility to the bottom wall 520a to enable the bottom
wall 520a to flex as shown in FIGS. 9-9A. Although catheters 400
and 500 are illustrated as single lumen catheters, it is envisioned
that the advantages discussed above with respect to catheters 400
and 500 are equally applicable to dual lumen catheters such as
shown in FIGS. 1-8 of this application.
[0045] Although not explicitly shown in the drawings, it is
envisioned that the bottom wall defining the recess in any one or
all of the embodiments disclosed herein may be non-linear in a
longitudinal or transverse direction. For example, the bottom wall
defining the recess may be undulating or have a wave-like or
irregular configuration in the longitudinal and/or transverse
direction. It is envisioned that such non-linear surface
configurations may further minimize the likelihood of occlusion of
the side opening.
[0046] Although each of the catheter embodiments discussed above
describes the recesses as being associated with each of the
diametrically located side openings, it is envisioned that the
recess may be associated with only a single side opening. Thus, in
a non-reversible dialysis catheter, the recess may be associated
only with the side opening which communicates with the arterial
lumen.
[0047] Although the illustrated embodiments include both distal
openings and side openings, it is envisioned that the catheter may
include only side openings which have recesses associated with one
or both of the side openings. In addition, athough this disclosure
illustrates embodiments of a dual lumen catheter, it is also
envisioned that the combination of a side opening and a recess is
applicable to a single lumen catheter.
[0048] In addition to the advantages described above with regard to
providing a recess that communicates with a side opening, it is
also believed that such a configuration provides further
advantages. More specifically, the provision of a recess that
communicates with a side opening results in smoother flow dynamics,
i.e., less flow disruption, into the side opening. By providing
smoother flow dynamics into the side opening, undue shear stress on
the fluid, e.g., blood, is minimized resulting in minimized
platelet aggravation and reduced thrombus. To maximize these
additional advantages in a dialysis catheter, the recess may be
positioned proximally of the side opening communicating with the
arterial lumen.
[0049] Persons skilled in the art will understand that the devices
and methods specifically described herein and illustrated in the
accompanying drawings are non-limiting exemplary embodiments. It is
envisioned that the elements and features illustrated or described
in connection with one exemplary embodiment may be combined with
the elements and features of another without departing from the
scope of the present disclosure. As well, one skilled in the art
will appreciate further features and advantages of the disclosure
based on the above-described embodiments. Accordingly, the
disclosure is not to be limited by what has been particularly shown
and described, except as indicated by the appended claims.
* * * * *